The CONTROL trial was designed to see whether the addition of budesonide or colestipol to loperamide prophylaxis could offset the high rates of neratinib-associated diarrhea seen in patients in the ExteNET trial. In the ExteNET trial, patients did not receive prophylaxis, instead, they were given loperamide (Imodium) as needed, says Shao.

Results of the study demonstrated that if patients received prophylaxis with loperamide and colestipol during the first cycle of therapy, there was a significant reduction in grade 3/4 diarrhea. With the regimen, the incidence of diarrhea went from 40% to 10%, says Shao. This approach resulted in a smaller discontinuation rate as well, she adds. As such, if a physician decides to proceed with neratinib for a patient, he/she should be ready to prescribe colestipol and loperamide prophylaxis as well.

The CONTROL trial was designed to see whether the addition of budesonide or colestipol to loperamide prophylaxis could offset the high rates of neratinib-associated diarrhea seen in patients in the ExteNET trial. In the ExteNET trial, patients did not receive prophylaxis, instead, they were given loperamide (Imodium) as needed, says Shao.

Results of the study demonstrated that if patients received prophylaxis with loperamide and colestipol during the first cycle of therapy, there was a significant reduction in grade 3/4 diarrhea. With the regimen, the incidence of diarrhea went from 40% to 10%, says Shao. This approach resulted in a smaller discontinuation rate as well, she adds. As such, if a physician decides to proceed with neratinib for a patient, he/she should be ready to prescribe colestipol and loperamide prophylaxis as well.